MUST READS

A breakthrough pancreatic cancer drug won approval. They still struggle to access it

STAT

STAT’s Angus Chen covered how drug approvals can complicate access to new medications:

“Approvals, of course, generally improve access to drugs that previously were only available on limited programs or in clinical trials. But for patients who are in the process of getting expanded access — often called compassionate use — they can turn what is meant to be a straightforward process into a labyrinth.”

Ominous outlook for Medicare drug spending

Axios

According to Axios, there are troubling signs that the overhaul of Medicare drug coverage in the Inflation Reduction Act is dramatically driving up program spending. The upward trajectory could threaten some seniors' coverage for outpatient prescription drugs — and it could force painful tradeoffs over the next decade as Medicare consumes a growing share of the nation's debt.

Court Says Vertex Fertility Perk Would Violate Statute

Bloomberg Law

A US appeals court said the maker of a sickle cell gene therapy’s program to offer fertility preservation services to patients would violate a federal anti-kickback law.

The US Court of Appeals for the District of Columbia Circuit on Friday affirmed a lower court decision finding that a program by Vertex Pharmaceuticals Inc., maker of multimillion-dollar sickle cell gene therapy Casgevy, would violate the federal anti-kickback statute “if undertaken with the requisite scienter” by offering fertility preservation services to address concerns that its product’s fertility risks might deter patients from taking it.

Drug pricing policy ‘earthquake’ forcing rethink of global commercialization plans: survey

FiercePharma

Healthcare consultancy Numerof & Associates fielded a survey of 175 executives from 67 pharmaceutical companies. The qualitative survey revealed the belief that the current era of policy change is unlike anything that the industry has experienced before. After going through a period of fast change, the industry is braced for more upheaval in the coming years. 

Trump Administration Working on More Drug Pricing Deals, Oz Says

Bloomberg

The Trump administration is pursuing additional drug pricing deals with pharmaceutical companies, Centers for Medicare and Medicaid Services Administrator Mehmet Oz told Bloomberg Television.

Officials have announced more than two dozen voluntary agreements with pharmaceutical companies so far, and Oz said “there are more deals in the works.” He spoke ahead of his scheduled keynote address at the Republican midterm convention in Dallas Wednesday night.

OTHER HEADLINES

• Health Affairs: Analyzing The Federal Trade Commission’s Pharmacy Benefit Manager Settlements
• Axios: Medicare Advantage plans appear to be cutting benefits in 2027
• Pink Sheet: US FDA Names Permanent CDER, CBER Directors, Creates AI Deputy Commissioner Post

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